Stories
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Technology Leaders: Materials
Modern evaluation of biocompatibility uses a risk-based approach.
Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
From the Editor: Regulations/Standards
New best practices for understanding medical device security.
Supplements: Sensors/Data Acquisition
In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Features: Test & Measurement
A robust, optimized mechanical testing program is essential to successful quality control testing.
Products: Materials
Linear stepper stages, tubing, Bluetooth modules, and more.
Supplements: Robotics, Automation & Control
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: Regulations/Standards
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: Design
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
Features: Test & Measurement
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
From the Editor: AR/AI
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Briefs: Medical
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Regulations/Standards
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: Software
FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production of...
Features: Test & Measurement
How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.
Features: Regulations/Standards
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
Briefs: Medical
In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...
Features: Software
Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...
Briefs: Medical
Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of these...
Features: Test & Measurement
The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...
News: Test & Measurement
As of September 2018, Instron’s Calibration Laboratory in Norwood, MA USA (NVLAP Lab Code 200301-0) expanded its global reach to include Europe into its existing operations. This addition...
Features: IoMT
Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...
Features: Electronics & Computers
The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.1,2 As with any new standard edition, there are...
Features: Medical
When validating the steam sterilization instructions for a reusable medical device,...
INSIDER: Manufacturing & Prototyping
A grant from the National Institute of Standards and Technology (NIST) will be used to to develop standards for regenerative medicine and biomaterial manufacturing. NIST awarded...
Features: Packaging & Sterilization
A key driver of the medical disposables market is the desire to minimize the risk of healthcare-associated infections (HAIs). Healthcare providers are turning to disposable products...
News: Test & Measurement
Medical Device Preclinical Bootcamp to Explore Testing Pathway
An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It will...
Features: Imaging
In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for Standardization...
Top Stories
INSIDER: Medical
Brain Implant Enables Safer Drug Delivery
Features: Medical
Built to Adapt: Rethinking Contract Manufacturing for a New Era
Podcasts: Design
Smarter Pathways for Precision Drug Delivery in Cancer Care
From the Editor: Medical
From The Editor: Charting the Technologies That Will Shape Medtech in 2026
Features: Materials
OEM Toll Processing Advances High-Value Products
Podcasts: Medical
Ask the Expert
Ralph Bright on the Power of Power Cords
Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.
Webcasts
Podcasts: Medical
How Wearables Are Enhancing Smart Drug Delivery
Podcasts: Design
Developing Sustainable Drug-Delivery Devices
Podcasts: Design
Smarter Pathways for Precision Drug Delivery in Cancer Care
On-Demand Webinars: Medical
Understanding Testing and Compliance Requirements for Wireless Medical Devices
Podcasts: AR/AI
Personalized Medicine and Drug Delivery
Podcasts: Manufacturing & Prototyping
Inside Story
Inside Story: Trends in Packaging and Sterilization
Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.
